Taurine supplementation for improving heart health in thalassemia patients

Thalassemic Iron Overload Cardiomyopathy is Ameliorated by Taurine Supplementation (TICATS Study)

This study is testing if adding taurine supplements to the usual iron treatment can help improve heart health in people with thalassemia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT04291352 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of taurine supplementation in combination with standard iron chelation therapy for patients with transfusion-dependent β-Thalassemia. Sixty participants will be randomly assigned to receive either a placebo or taurine alongside their ongoing iron chelation treatment. The study aims to assess the impact of this combination on cardiac iron overload, oxidative stress, and cardiac function over a 12-month period using cardiac MRI and clinical evaluations. Monthly transfusion and safety visits will ensure participant monitoring throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with transfusion-dependent β-Thalassemia who are on stable iron chelation therapy.

Not a fit: Patients with severe iron overload or those requiring frequent transfusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce cardiac damage and improve heart health in patients with thalassemia.

How similar studies have performed: While taurine's role in this context is novel, previous studies have shown promise in using dietary supplements to enhance treatment outcomes in similar conditions.

Eligibility criteria

Participant inclusion criteria

Participants who meet all of the following criteria will qualify for entry into the study:

1. Diagnosis of transfusion-dependent Thalassemia being followed at the RBC clinic at TGH
2. Age 18 or older
3. On a stable dose of iron chelation for \>30 days. Combination iron chelation regimen is allowed in the study
4. Cardiac MRI T2\* ≥8ms measured within 3 months prior to randomization.
5. Preserved left ventricular ejection fraction (LVEF) \>50% as measured by cardiac MRI measured within 3 months prior to randomization.

Participant exclusion criteria

Participants who meet any of the following criteria will be excluded from the study:

1. More than 16 transfusions in the past 12 months or those who are anticipated to be on a 3 week transfusion schedule during the study period
2. Serum ferritin \< 500 ng/mL at screening
3. Liver iron concentration \> 40 mg/g dw as measured by liver R2 MRI (FerriScan) measured within 3 months prior to randomization
4. Signs and symptoms consistent with congestive heart failure in the opinion of the investigator
5. As a result of medical review, physical examination or screening investigations, the investigator considers the subject unfit for the study.
6. No fixed address
7. Interval advent of general contraindications to MRI.
8. Taking another investigational product within 30 days of anticipated date of randomization
9. Women who are currently pregnant or plan to become pregnant during the study period

Where this trial is running

Toronto, Ontario

• University Health Network — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Anneliesse Justiniano

Conditions Thalassemia Major